Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)
This study is ongoing, but not recruiting participants.
Sponsor:
Glaukos Corporation
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00913029
First received: June 1, 2009
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Eye Diseases Glaucoma, Open-Angle Glaucoma |
Device: iStent Drug: latanoprost/timolol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma |
Resource links provided by NLM:
Further study details as provided by Glaukos Corporation:
Primary Outcome Measures:
- Mean intraocular pressure (IOP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
|
Device: iStent
iStent
Other Name: stent, Trabecular micro bypass
|
|
Active Comparator: Medication
One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.
|
Drug: latanoprost/timolol
Combination latanoprost/timolol
|
Detailed Description:
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of primary open-angle glaucoma
- Male or female at least 18 years of age and able to provide written informed consent
- Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
- Likely to be available and willing to attend follow-up visits
Exclusion Criteria:
- Angle closure glaucoma
- Secondary glaucomas
- Prior glaucoma procedures
- Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913029
Locations
| Austria | |
| Allgemeines Krankenhaus Wien | |
| Wien, Austria, 1090 | |
| France | |
| CHU de Lyon Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| CHNO des Quinze-Vingts | |
| Paris, France, 75012 | |
| Germany | |
| Knapschaftskrankenhaus Bochum Langendreer | |
| Bochum, Germany, 44892 | |
| Helios Cliniic | |
| Erfurt, Germany, 99089 | |
| Universitatsklinkum Erlangen | |
| Erlangen, Germany | |
| Greece | |
| AHEPA Hospital | |
| Thessaloniki, Greece, 546 36 | |
| Italy | |
| Universita'degli Studi di Parma | |
| Parma, Italy, 43100 | |
| Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica | |
| Torino, Italy, 10128 | |
| Azienda Ospedaliera S. Maria della Misericordia | |
| Udine, Italy, 33100 | |
| Poland | |
| Military Health Service Institute | |
| Warsaw, Poland, 00-909 | |
| Spain | |
| Hospital Torrevieja Salud, UTE | |
| Alicante, Spain, 03186 | |
| Hospital Clinico San Carlos | |
| Madrid, Spain, 28040 | |
Sponsors and Collaborators
Glaukos Corporation
Investigators
| Study Director: | Jeff Wells, PharmD, MBA | Glaukos Corporation |
More Information
No publications provided
| Responsible Party: | Glaukos Corporation |
| ClinicalTrials.gov Identifier: | NCT00913029 History of Changes |
| Other Study ID Numbers: | Second Line, Second Line Trial |
| Study First Received: | June 1, 2009 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Italy: Ethics Committee Poland: Ministry of Health Greece: Ethics Committee Austria: Ethikkommission Germany: Ethics Commission Spain: Ethics Committee France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Glaukos Corporation:
|
primary open angle glaucoma (POAG) OAG glaucoma |
Additional relevant MeSH terms:
|
Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Latanoprost Antihypertensive Agents Timolol Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on May 22, 2013